Bowing to safety concerns, government medical advisers urged on Thursday that additional restrictions be put on the use of drugs that treat anemia in cancer patients.

The recommendations by an advisory committee to the Food and Drug Administration followed a flurry of studies suggesting that the drugs, meant to help patients cope with chemotherapy, might actually be making their cancer worse or hastening their deaths.

The drugs — Aranesp from Amgen and Procrit from Johnson & Johnson — are used by about a half-million American cancer patients a year and have billions of dollars in annual sales.

Some members of the committee expressed shock that even though Procrit was first approved 14 years ago, it was still not clear if the drugs were safe at the doses typically used.

“Yes, we have a burning question,” one panel member, Dr. Silvana Martino, an oncologist in Santa Monica, Calif., said at the meeting here. “Do these things kill people?”

Legislation to beef up drug safety, passed by the Senate this week with only one dissenting vote, grew out of an extraordinary pact between two senators and a frantic effort by the pharmaceutical industry to avoid any disruption in the approval of new drugs.

The bill would increase the fees paid by drug makers to help finance the work of the Food and Drug Administration and would give the agency new power to police company conduct.

Industry lobbyists and executives said they supported the bill for one overriding reason: pink slips.

Sometime this summer, if a bill has not passed, medical officers at the F.D.A. will start getting notices that they are in danger of being laid off by the end of the fiscal year on Sept. 30. Some of those officers are likely to be in the midst of reviewing new drug applications crucial to the future of drug makers.

If those medical officers leave, drug approvals may be delayed — a terrifying prospect for many companies.

As we mentioned yesterday, Purdue Pharma's parent company and three top executives pleaded guilty to deceptive marketing practices in connection with downplaying the addictive properties of the narcotic pain medication OxyContin. Here's today's updated New York Times article, with further information and links to the plea agreements. The new article adds information about the relationship between the plea deal and the civil litigation:

Of the $600 million in payments, Purdue Frederick will pay $470 million in fines and payments to a variety of federal and state agencies.

It also agreed to pay at least $130 million to resolve civil lawsuits brought by pain patients who claimed they became addicted as a result of having OxyContin prescribed to them. A lawyer for one company executive said that much, if not all, those funds have been paid out in the process of settling lawsuits. There are still claims against the company by private plaintiffs.

This week, Purdue agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.

Pleading guilty to federal criminal charges and paying $600 million can't be fun, although according to the Times article, some think that the fines should have been higher. But as a matter of mass tort litigation strategy, it seems to me that the company made out pretty well. Timing is everything.

Ordinarily, a criminal plea like this one would trigger massive litigation and vastly improve plaintiffs' leverage. The guilty plea could bring new plaintiffs out of the woodwork, could attract more plaintiffs' counsel to the litigation, could encourage those already in it to invest more heavily, could alter the momentum of the litigation, could affect jurors' attitudes, and in some jurisdictions, could bind the company as a matter of offensive nonmutual issue preclusion. I've written in the past about "coattail class actions" -- private mass litigation that follows government actions.

But in the OxyContin litigation, the defendant previously defeated many individual plaintiffs, and then reportedly settled 90% of the remaining cases on the cheap about four months ago. Add the passage of time and the benefit of the statute of limitations, and it appears likely that this criminal plea won't do the kind of damage one ordinarily would expect in the mass tort context.

According to an article in today's NY Times, the manufacturer of OxyContin is expected to plead guilty and pay over $600 million in fines in connection with its marketing of the painkiller. Numerous civil lawsuits have been brought concerning the addictiveness of OxyContin, but until recently plaintiffs had not had notable success. According to today's article, some of the funds from the criminal and civil penalties will be used to settle civil lawsuits. Here's an excerpt from Barry Meier's article:

The company that makes the narcotic painkiller OxyContin and three current and former executives are expected to plead guilty today in federal court here to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused, federal officials said.

To resolve criminal and civil charges related to the drug’s “misbranding”, the parent of Purdue Pharma, the company that markets OxyContin, has agreed to pay more than $600 million in fines, these officials said. That is the third-highest amount ever paid by a drug company in such a case.

Also, in a rare move, three executives of Purdue Pharma, including its president and it top lawyer, are expected to plead guilty today as individuals to misbranding charges, a criminal violation. They have agreed to pay a total of $34.5 million in fines, said these officials, who spoke on the condition of anonymity because court proceedings have not been completed.

... In a proceeding scheduled this morning in United States District Court in Abingdon, Va., both Purdue Pharma and those executives are expected to acknowledge that the company fraudulently marketed OxyContin for six years as a drug that was less prone to abuse as well as one that also had fewer narcotic side effects.

Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.

Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year.

In the wake of the tainted pet-food scandal, some pet owners, aided by trial lawyers and advocacy groups, are trying to achieve human-like status for their animals in our civil courts. If they succeed, it may become much more costly -- and risky -- to own a pet in America.

Many of America's estimated 65 million dog and cat owners are justifiably outraged at the news that popular brands of pet food were contaminated by the chemical melamine. Although the Food and Drug Administration has attributed only 16 dog and cat deaths to the contamination, veterinarians have reported thousands of cases of renal distress and failure since shortly after a large maker of pet foods began importing wheat gluten and rice concentrate from China. FDA inspectors are now investigating whether Chinese importers purposely spiked the food with melamine because the chemical shows up as protein on nutritional tests.

The crisis has prompted some 50 class action lawsuits against domestic pet-food brands by trial lawyers who are recruiting owners of stricken pets as clients. Under traditional legal precedent, the damages in these cases are limited to what you paid for your pet and what you've spent in food and vet care, plus any additional bills for having your pet treated for food poisoning. But trial lawyers and some animal-rights activists are hoping to persuade legislators and the courts to allow judgments for noneconomic damages, including awards that take into account the pain and suffering of owners.

Amgen Inc. and Johnson & Johnson may have to further limit the targeted patient population and dosing levels for popular anti-anemia drugs to reduce risks to cancer patients, U.S. regulators said Tuesday.

Such moves could cut into sales for the blockbuster drugs. Already, safety concerns have slowed the growth of Amgen's Aranesp sales. Amgen relies on Aranesp and another anemia drug for nearly half of its revenue.

The Food and Drug Administration raised concerns about Aranesp and J&J's Procrit ahead of an agency meeting of outside experts scheduled for Thursday. The panel will consider whether to further modify the drugs' product labeling in the wake of recent safety concerns.

In documents posted on the agency's Web site Tuesday, the FDA said: "Further modifications to product labeling may be appropriate to minimize risks to patients, through restrictions of the indicated patient population or further limitations on dosing to achieve the minimal hemoglobin level necessary to avoid transfusions."

Article in the Cincinnati Post about plans to mediate the dispute in which hundreds of fen-phen clients accuse their former lawyers -- Shirley Cunningham, William Gallion, Melbourne Mills, and Stan Chesley -- of defrauding them in connection with the aggregate settlement of their claims against Wyeth. If mediation fails, however, plaintiffs' attorney Angela Ford is seeking a change of venue from Boone County to Lexington. Here's an excerpt from the April 24 article by Shelly Whitehead, Fen Phen Suit Heads to Mediation:

The attorney for hundreds of people who say lawyers representing them in a suit against the diet drug fen-phen defrauded them will try to settle their differences in mediation sessions next month. If that doesn't work, however, an attorney representing the more than 400 plaintiffs in the case wants the trial of their suit moved from Boone County, Ky., to Lexington. ...

In 2002, fen-phen maker American Home Products and more than 400 people who took the drug in Kentucky reached a $200 million settlement. Cunningham, Gallion and Mills, the original attorneys for plaintiffs in the case, hired Chesley to negotiate that agreement.

The victims in that case wound up splitting $74 million and the lawyers and their associates got $106 million. The plaintiffs complained that was more than had been agreed upon, and hired Ford to represent them in an effort to recover some of that money.

A year ago, [Judge William] Wehr ruled the three main lawyers in the original case had misappropriated settlement money and breached their fiduciary duties. The Kentucky Supreme Court later suspended the licenses of that trio. ...

If mediation between the parties - set for May 16 and 17 - fails to resolve that issue, the matter will go to trial, and a jury will determine how much money the attorneys must return to the original plaintiffs. ...

Wehr scheduled another hearing for May 31 at the Burlington courthouse to determine what, if any, progress has been made during mediation and how the case will proceed.

Doctors reported yesterday that expectant mothers with epilepsy who took a commonly prescribed drug to control seizures were at increased risk of having a child with mental deficits.

Toddlers who had been exposed in the womb to the drug Depakote, from Abbott Laboratories, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study found. They were twice as likely to score in the range associated with mental retardation, according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston.

Other researchers said the findings should be considered preliminary because I.Q. measures were less reliable in 2-year-olds than in older children; the study will continue, tracking children through age 6.

The report is consistent with several recent studies finding that Depakote is more likely than other so-called anticonvulsant drugs to increase the risk of mental deficits and other birth defects, like neural tube problems. An estimated 24 million American women have taken these drugs — which include Tegretol from Novartis, Lamictal from GlaxoSmithKline and Dilantin from Parke Davis — for an array of problems, including epilepsy, bipolar disorder and migraine headaches, according to an analysis by the Epilepsy Foundation.